Pilot study: miscellaneous therapy is highly successful for Helicobacter pylori eradication

Success in H. pylori eradication with conventional therapies has decreased to unacceptable levels (≤80%). New schemes of combined treatment are currently needed.

To test a miscellaneous therapy for H. pylori eradication.

Open-label, pilot, single-centre and prospective study. Patients received a 15-day treatment scheme that consisted of 5 initial days of lansoprazole 30 mg b.d., amoxicillin 1 g b.d., and metronidazole 500 mg t.d.s.; days 6 to 10: lansoprazole 30 mg q.d.s. and metronidazole 500 mg t.d.s.; days 11 to 15: lansoprazole 30 mg b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg t.d.s. Each patient underwent an upper endoscopy before treatment and a second follow-up endoscopy at least 4 weeks after therapy. Success was defined on the basis of an eradication rate following a per-protocol analysis ≥95%. Biopsies before and after therapy were obtained for histological evaluation and rapid urease test.

One hundred and twenty-two patients were enrolled and 118 patients completed the study. The eradication rate for H. pylori with miscellaneous therapy was 94% (confidence Interval (CI) 95%, 90-98.3%) in the per-protocol analysis (PP) and 91% (95% CI, 86-96%) in the intention-to-treat (ITT) analysis. Adherence to treatment was 96% (113 patients). Among patients who completed treatment, 55% presented adverse events, mainly nausea and abdominal pain.

A miscellaneous therapy, based on the combination of multiple medications in high doses for 2 weeks, and with gastric pH elevation, is a highly effective treatment as a first-line therapy for the eradication of H. pylori.